MAUDE Adverse Event Report: HILL-ROM CARY MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS); WAVE CLINICAL PLATFORM

Model Number NG

Device Problem Device Alarm System (1012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2023

Event Type  malfunction  

Manufacturer Narrative

The wave clinical platform is software intended to route, store, and display data, alarms, results and diagnostic information from medical devices, electronic medical records (emr), and clinical information systems (cis).The wave clinical platform is a remote monitoring platform that displays physiologic data, waveforms, alarms, results and diagnostic information routed through the platform from supported devices and systems.The wave clinical platform is intended for use in hospital or hospital type environments.The wave clinical platform is intended to be used by healthcare professionals for the following purposes: to remotely consult regarding patients¿ statuses; to remotely review other standard or critical near real-time patient data, waveforms, alarms, and results in order to utilize this information to aid in clinical decisions.The user manual contains warnings such as "the wave clinical platform is intended to supplement and not replace any part of the hospital's device monitoring or electronic data management systems.Do not rely on the wave clinical platform product as the sole source of alarms".Troubleshooting found the issue to be due to a software bug, the service was rebooted.There was no reported injury as a result of this event, however; a software error which may result in cancelled alarms, could be likely to result in serious injury or death if it were to recur.Therefore, hillrom is reporting this malfunction.

Event Description

The customer reported that the rrt and staff assist calls cancelled themselves immediately after being triggered and the monitor displayed an "unrecognized expression" error message.This incident was captured under hillrom complaint ref # (b)(4).

• Brand Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Type of Device: WAVE CLINICAL PLATFORM
• Manufacturer (Section D): HILL-ROM CARY; 1225 crescent green dr., suite 300; cary NC 27518
• Manufacturer Contact: keighley crosthwaite ; 1225 crescent green dr., suite 300; cary, NC 27518 ; 8129310130
• MDR Report Key: 16761216
• MDR Text Key: 313498429
• Report Number: 2027454-2023-00033
• Device Sequence Number: 1
• Product Code: MWI
• UDI-Device Identifier: 00856128007007
• UDI-Public: 00856128007007
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: NG
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1